PMA P100024S004
- Device
- HER2 CISH PHARMDX KIT
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S004
- Product code
- NYQ
- Decision date
- 2013-04-19
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Approval order statement
- APPROVAL FOR THE DAKOLINK V4.0 SOFTWARE FOR HER2 CISH PHARMDX¿ KIT.
Current openFDA PMA Record#
- Device
- HER2 CISH PHARMDX KIT
- Applicant
- Dako Denmark A/S
- PMA number
- P100024
- Supplement
- S004
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2013-04-19
- Decision code
- APPR
- Date received
- 2012-11-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE DAKOLINK V4.0 SOFTWARE FOR HER2 CISH PHARMDX¿ KIT.